8/1/2022

Protamine Sulfate Injection

Reason for the Shortage

- Fresenius Kabi had protamine on shortage due to manufacturing delays. A customer letter detailing the issue can be found at: http://editor.fresenius-kabi.us/PIUs/Protamine_Sulfate_Supply_Update_04_16_2021.pdf.

Available Products

- Protamine injection, Fresenius Kabi, 10 mg/mL, 25 mL vial, 1 count, NDC 63323-0229-30
- Protamine injection, Fresenius Kabi, 10 mg/mL, 5 mL vial, 25 count, NDC 63323-0229-05

Estimated Resupply Dates

- Fresenius Kabi has protamine 10 mg/mL 5 mL and 25 mL vials available. Check wholesalers for inventory.

Alternative Agents & Management

- Consider using bivalirudin for cardiopulmonary bypass surgery to prevent the need for protamine due to heparin use. The Society of Thoracic Surgeons, Society of Cardiovascular Anesthesiologists, and the American Society of ExtraCorporeal Technology created clinical practice guidelines for anticoagulation during cardiopulmonary bypass that were published in 2018. These can be found at https://www.annalsthoracicsurgery.org/action/showPdf?pii=S0003-4975%2817%2931478-9. These include dosing information from the CHOOSE-ON and EVOLUTION-ON trials.
- Bivalirudin starting doses in the CHOOSE-ON and EVOLUTION-ON trials included a loading dose of 1 mg/kg, maintenance infusion of 2.5 mg/kg/hr, and pump prime bolus of 50 mg.

Updated

Updated August 1, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. Created March 2, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2022, Drug Information Service, University of Utah, Salt Lake City, UT.

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